Lithotripsy for the Treatment of Gallstones

Phase 4

Terminated

• Conditions: Cholelithiasis

• Registration Number: NCT00042549
• Lead Sponsor: Medstone International

Brief Summary

The purpose of this study is to determine the effectiveness and safety of using the Medstone lithotripter to treat single non-calcified gallstones from 4 to 20 mm in diameter.

Detailed Description

This study is a randomized, single-masked controlled trial in which the combination therapy of lithotripsy and the bile acid drug Actigall is compared to monotherapy with only Actigall. The primary objectives are, 1) To determine whether the use of the Medstone STS Lithotripter system in combination with the orally administered drug Actigall is more effective (as measured by percentages of stone free patients 6 months after randomization) in reducing single non-calcified radiolucent gallstones (from 4 to 20mm in diameter) than use of Actigall alone, and 2) To demonstrate that use of the Medstone lithotripsy system is safe (as measured by incidence of adverse events) for the intended purpose, when operated according to its labeling.

Study Timeline

• Study Start: 2002-05
• Study First Submitted: 2002-07-31
• Study First Submitted QC: 2002-08-02
• Study First Posted: 2002-08-05
• Status Verified: 2003-06
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (2)

The Methodist Hospital; 🇺🇸 Houston, Texas, United States

Virgina Commonwealth University; 🇺🇸 Richmond, Virginia, United States